Method and apparatus for fine adjustment of a percutaneous valve structure

ABSTRACT

The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.

This application is a continuation of U.S. patent application Ser. No.12/686,340, filed Jan. 12, 2010 and claims the benefit of priority ofU.S. Provisional Application Ser. No. 61/144,007, filed Jan. 12, 2009,all of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to an adjustment mechanism for finelyadjusting the position of a percutaneous prosthetic valve devices. Theinvention further relates to a method of positioning a percutaneousprosthetic valve in a target location of a body lumen with enhancedaccuracy. The apparatus and method of the invention are applicable topre-assembled valve devices or modular valve devices, i.e., a prostheticvalve capable of being delivered in parts and assembled in the body.

BACKGROUND OF THE INVENTION

The human body contains a wide variety of natural valves, such as, forexample, heart valves, esophageal and stomach valves, intestinal valves,and valves within the lymphatic system. Natural valves may degeneratefor a variety of reasons, such as disease, age, and the like. Amalfunctioning valve fails to maintain the bodily fluid flow in a singledirection with minimal pressure loss. An example of a malfunctioningvalve is a heart valve that may be either stenotic, i.e., the leafletsof the valve do not open fully, or regurgitant, i.e., the leaflets ofthe valve do not close properly. It is desirable to restore valvefunction to regain the proper functioning of the organ with which thevalve is associated. For example, proper valve function in the heartensures that blood flow is maintained in a single direction through avalve with minimal pressure loss, so that blood circulation and pressurecan be maintained. Similarly, proper esophageal valve function ensuresthat acidic gastric secretions do not irritate or permanently damage theesophageal lining.

Several percutaneous prosthetic valve systems have been described. Oneexample described in Andersen, et. al. (U.S. Pat. No. 5,411,552)comprises an expandable stent and a collapsible valve which is mountedonto the stent prior to deployment. Spenser, et. al. (U.S. Pat. No.6,893,460) describe another prosthetic valve device comprising a valvestructure made of biological or synthetic material and a supportingstructure, such as a stent. The Spenser prosthetic valve is a crimpableleafed-valve assembly consisting of a conduit having an inlet and anoutlet, made of pliant material arranged to present collapsible walls atthe outlet. The valve assembly is affixed to the support stent prior todeployment. The complete valve device is deployed at a target locationwithin the body duct using a deploying means, such as a balloon catheteror a similar device. Percutaneous implantation of medical devices,particularly prosthetic valves, is a preferred procedure because itallows implantation without the need for opening a large portion of thechest.

Accurate placement of current percutaneous valve devices relative to theexisting native anatomy is often problematic, particularly in the caseof aortic valve replacements. Consequences of poor valve placement inthe case of an aortic valve include functional and/or physical occlusionof the orifice of the coronary artery distal to the aortic valve, and/orincreased pressure on and disruption of the electrical conductionapparatus of the heart. Specifically, a prosthetic valve that is placedtoo distally (i.e., toward the aorta) can occlude or impede flow intothe orifices of the coronary arteries. For example, depending on theposition of the coronary ostia, either the skirt of the prosthetic valveor large native valve leaflets pressed down against the aorta wall mayphysically or functionally obstruct the orifices and impede coronaryarterial flow. See, e.g., Piazza, N., et al., “Anatomy of the AorticValvar Complex and Its Implications for Transcatheter Implantation ofthe Aortic Valve,” CIRCULATION CARDIOVASCULAR INTERVENTIONS, 1:74-81(2008); Webb, J G, et al., “Percutaneous aortic valve implantationretrograde from the femoral artery,” CIRCULATION, 113:842-850 (2006).This obstruction may be either physical or it may be functional, i.e.,the orifices of the coronary arteries are physically patent, but due toalterations in flow patterns produced by the prosthetic valve, flow intothe coronary arteries is partially impeded. A prosthetic valve that isplaced too proximally (i.e., toward the ventricular outflow tracts ofthe left ventricle) can interfere with the anterior leaflet of theMitral valve, the atrioventricular node or the bundle of His (conductiontissues). Approximately thirty percent of patients receiving prostheticvalves percutaneously require pacemakers, because the valve is placedwith the ventricular end too close to or on top of the left bundlebranch, putting pressure on the electrical conduction apparatus. See,e.g., Piazza, N., et al., “Early and persistent intraventricularconduction abnormalities and requirements for pacemaking followingpercutaneous replacement of the aortic valve,” JACC CARDIOVASCULARINTERVENTIONS, 1:310-316 (2008); Piazza, N., et al., “Anatomy of theAortic Valvar Complex and Its Implications for TranscatheterImplantation of the Aortic Valve,” CIRCULATION CARDIOVASCULARINTERVENTIONS, 1:74-81 (2008).

Persons of skill in the art recognize that one limitation onpercutaneous prosthetic aortic valve replacement methods using currentlyavailable pre-assembled valve devices is a less than desirable level ofprecision for positioning the valve. See Ussia, G. P., et al., The“Valve-in-Valve Technique: Transcatheter Treatment of AorticBioprosthesis Malposition,” CATHETERIZATION CARDIOVASCULARINTERVENTIONS, 73:713-716 (2009); Ghanbari, H., et al., “PercutaneousHeart Valve Replacement: An Update,” TRENDS CARDIOVASCULAR MEDICINE,18:117-125, (2008); Lutter, G., et al., “Percutaneous Valve Replacement:Current State and Future Prospects,” ANNALS THORACIC SURGERY,78:2199-2206 (2004).

Repositioning methods have been proposed. Such methods involve arepositioning of the entire valve device rather than adjustment from theprevious position. One method of repositioning a percutaneous prostheticvalve involves compressing or relaxing the stent that serves as theframe for the valve. See Zegdi, R. et al., “A Repositionable Valve Stentfor Endovascular Treatment of Deteriorated Bioprostheses,” J. AMERICANCOLLEGE CARDIOLOGY, 48(7):1365-1368 (2006). Such a method provideslittle if any fine control over the axial position or angular positionof the valve, and risks significant shifting of the entire device and/ordamage to the tissue. Another method of repositioning a percutaneousprosthetic valve involves preventing the stent from fully expandinguntil it is in position, or unexpanding the stent slightly in order toreposition it. Buellesfeld, et al., “Percutaneous Implantation of theFirst Repositionable Aortic Valve Prosthesis in a Patient with SevereAortic Stenosis,” CATHETERIZATION CARDIOVASCULAR INTERVENTIONS,71:579-584 (2008); US Published Application No. 2005/0137688A1 toSalahieh et al. Such a method provides little if any fine control overthe axial position or angular position of the valve, and repeatedexpansion and compression of the stent at or near the site ofimplantation risks damage to the tissue.

Therefore, there is a need in the art for an apparatus and method formaking fine adjustments to a valve's position after implantation—i.e.,to move the valve in small increments until the proper position isachieved. This adjustment method provides an iterative feedback processwhere each adjustment is an incremental improvement over the lastposition. A need also exists for a method of delivering a prostheticvalve with increased safety, e.g., with minimal damage to the vesselwall and with good control of the adjustment process. A device that canbe placed in the vessel without incurring further damage to the wall ofthe body lumen during delivery and/or during adjustment of the valveposition—e.g., adjusting the valve, not the frame—is highly desirable.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a percutaneous prostheticvalve device that includes a mechanism for fine tuning the positions ofthe valve relative to the frame that seats the valve. It also is anobject of the invention to provide a percutaneous valve device that isminimally invasive during delivery and comprises a mechanism by whichthe position of the valve relative to the frame may be finely adjusted.Another object of the invention is to provide a method of percutaneousdelivery of a percutaneous valve device, that includes an iterativefeedback process for adjusting the position of the device. A furtherobject of the invention is to provide a method of placing a prostheticvalve device percutaneously in a lumen with reasonable accuracy, andsubsequently finely adjusting the valve position.

The present invention provides an apparatus and method to finely adjustthe position of the valve member of a percutaneous prosthetic valvedevice. The apparatus for adjusting the position of the valve member isan adjustment mechanism. The adjustment mechanism according to thepresent invention includes a means for adjusting the axial position ofthe valve member (i.e., the position along the longitudinal axis of thedevice) and/or a means for adjusting the angular position of the valvemember relative to the device frame. The adjustment mechanism of theinvention may also comprise a position-maintaining means, similar to alocking mechanism.

The adjustment mechanisms of the invention permit a relative range ofmotion between the valve member and the device frame of the prostheticvalve device, and therefore allow for optimization of the valve member'saxial and/or angular position after and/or during implantation. Forexample, where the device frame is anchored to the native vessel/tissue,axial adjustment of the valve member relative to the device frame alsoprovides axial adjustment of the valve member relative to the nativevessel/tissue. The adjustment mechanism of the invention may include afirst structure located on the valve member and a second structure onthe device frame, which first and second structures make up acomplementary configuration pair. The complementary configuration pairpermits adjustment of the position of the valve member relative to thedevice frame. The first and/or second component of the complementaryconfiguration pair may be an inherent structural feature of the valvemember or device frame.

The present invention is applicable to both a modular prosthetic valvedevice, which comprises a plurality of device modules that are deliveredand then assembled in vivo, and a pre-assembled percutaneous valvedevice. For example, pre-assembled percutaneous valves may bemanufactured to include the adjustment mechanisms of the presentinvention, so that after delivery the valve member may be adjustedrelative to the device frame.

Advantages that may be achieved by means of the present inventioninclude the ability to finely and more accurately adjust the position ofthe valve device. Another advantage of the present invention is theability to initially implant the percutaneous valve device with slightlyless accuracy and thereby quickly regain valve function, because theadjustment mechanism permits post-implantation fine-tuning of theposition of the valve. Another advantage of the present invention, whenused with a modular valve device, is that the reduced bulkiness of themodular valve device permits use of a smaller delivery device andincreases flexibility of the loaded delivery device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B illustrate a quick-release mechanism for adjusting andlocking a valve module to a support structure.

FIG. 2 illustrates a controlled snap-fit mechanism for adjusting andlocking a valve module to a support structure.

FIGS. 3A-3B illustrate a ratchet positioning mechanism for adjusting andlocking a valve module to a support structure.

FIGS. 4A-4C illustrate a snap rivet mechanism for adjusting and lockinga valve module to a support structure.

FIG. 5 illustrates a free suspense mechanism for adjusting and locking avalve module to a support structure.

FIG. 6a illustrates a helix rail fine tuning mechanism for adjusting andlocking a valve module to a support structure.

FIG. 6b illustrates a helix groove mechanism for adjusting and locking avalve module to a support structure.

FIG. 7 illustrates an embodiment of posts on a device frame for use withan adjustment mechanism.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides an adjustment mechanism for performingfine adjustment to the position of the valve member of a prostheticvalve device, a prosthetic valve device that includes such an adjustmentmechanism, and a method of adjusting the position of a valve member of aprosthetic valve device. In particular, the present invention providesan adjustment mechanism for either a modular percutaneous prostheticvalve device or a pre-assembled percutaneous valve device. Theadjustment mechanism of the invention permits the operator to finelyposition the valve member of the percutaneous valve device afterimplantation of the valve device, by moving the valve member in fineincrements axially and/or angularly relative to the device frame (forexample a support structure of a modular percutaneous valve device orthe frame of a pre-assembled percutaneous valve device), and relative tothe native vessel in which the device frame has been implanted. By“valve member” is meant the portion of the prosthetic valve device thatincludes leaflets which open and close to permit one-way fluid flow,similar to the action of a normally functioning native valve, and inmany cases a definable inlet end and outlet end. By “device frame” ismeant the portion of the prosthetic valve device that functions to seatthe valve member at the implantation site and anchor it there. Theinvention further provides a system for improved positioning of a valvemember in a body lumen and a method for facilitating accuratepositioning of the valve member in the body lumen.

The present invention may include a means for selectively maintainingthe position of the valve member relative to the device frame, as wellas resetting the position, e.g., by appropriate application of force ina particular direction. The invention further encompasses methods ofadjusting the position of a valve member relative to a device frameafter delivering a prosthetic valve to a body lumen in need thereof.

The adjustment mechanism according to the present invention encompassesa means for adjusting the position of the valve member in an axialdirection and/or a means for adjusting the position of the valve memberin an angular direction. In general terms, the adjustment mechanism ofthe invention comprises a complementary configuration pair that includeson the valve member a first structure having a first configuration andon the device frame a structure having a second configuration. Thedevice frame, which seats the valve member at the implantation site, maybe, e.g., a support structure of a modular valve device. The first andsecond structures have complementary configurations because theypreferably fit together to allow controlled relative motion between thevalve member and the device frame. For example, in one embodiment, thecomplementary configuration pair comprises a helical rail and a rollerthat fits on the rail. In another embodiment, the complementaryconfiguration pair may be a angular ridges and angular grooves.

In some embodiments, the adjustment mechanism may include aposition-maintaining means. In general, the position-maintaining meansis a physical or magnetic force that only allows the device's positionto be advanced upon application of a proper amount and direction offorce, such as arrangements where a pin or ridge fits into any one of aplurality of variously or serially positioned slots or ratchet-typeconfigurations. For example, button and harbor complementaryconfiguration pair may be designed so that the button is spring-loadedsuch that a threshold amount of force against the button is required topush the button out of the harbor. In another embodiment, thecomplementary pair configuration may be designed in a manner that allowsadvancement of the valve member relative to the device frame uponapplication of a threshold amount of force in a particular direction,similar to a ratchet mechanism.

The devices, systems and methods are particularly adapted for use inpercutaneous aortic valve replacement, but may also find use asreplacements for other cardiac valves, such as, e.g., pulmonic, mitraland tricuspid valves, as well as valves in the peripheral vasculature orin other bodily lumens, such as the alimentary canal, e.g., esophagus;lymph ducts; the biliary duct; and any other lumens having valvesrequiring replacement or needing valve implantation. Where thepercutaneous valve device is a modular valve device designed to replacean aortic valve, it may be assembled for example in the ascending aorta,the descending aorta, the left ventricle, at the implantation site, orpart at the implantation site and part in the aorta. Althoughparticularly adapted for use in lumens of the human body, the devices,systems and methods may also find application in animals.

The aforementioned embodiments, as well as other embodiments, deliverymethods, different designs and different types of devices are discussedand explained below with reference to the accompanying drawings. Notethat the drawings are provided as an exemplary understanding of thepresent invention and to schematically illustrate particular embodimentsof the present invention. The skilled person will readily recognizeother similar examples equally within the scope of the invention. Thedrawings are not intended to limit the scope of the present inventiondefined in the appended claims.

The adjustment mechanism permits fine adjustment of the position of thevalve member relative to the device frame of the prosthetic valve deviceby a variety of means. Exemplary embodiments of adjustment mechanismswithin the scope of the invention are illustrated in FIGS. 1-7 withreference to modular percutaneous valve devices that are delivered inparts and assembled in the body. However, the invention may also beapplied to non-modular, pre-assembled prosthetic valve devices. Modularvalve devices are described in detail in ¶¶29-30, 32-34, 39-49 and FIGS.1-4c of priority U.S. provisional application No. 61/144,007, in¶¶37-47, 60-62, 65-82 and FIGS. 1-6c of co-pending U.S. patentapplication Ser. No. 12/686,335 (modular), entitled “ModularPercutaneous Valve Structure and Delivery Method”, filed on date evenherewith, and in ¶¶43, 48-57 and FIGS. 1-4b of co-pending U.S. patentapplication Ser. No. 12/686,338 (self-assembly), entitled“Self-Assembling Modular Percutaneous Valve and Methods of Folding,Assembly and Delivery,” filed on date even herewith, which applicationsare incorporated herein by reference. Briefly, the modular valve devicecomprises a plurality of device modules for delivery. For example, theplurality of device modules may include a valve module and a supportstructure, which are designed to be assembled in the body. The valvemodule is the portion of the valve device having leaflets and onceassembled provides a conduit having a inlet end and an outlet end. Thevalve module may itself comprise a plurality of device modules. Thus, inone embodiment, the valve module may further comprise a plurality ofvalve sections, which may be assembled in vivo to form a valve assembly.A valve assembly of the modular valve device is the equivalent of thevalve member in accordance with the present invention. The supportstructure provides the framework, or backbone, of the device, housingthe valve module and holding the valve module in place within the body.A support structure of the modular valve device is the equivalent of thedevice frame in accordance with the present invention.

In an embodiment of the present invention illustrated in FIGS. 1A and1B, the adjustment mechanism comprises a quick-release button lockingmechanism comprising “buttons” 105 or “bumps” as a first structure inconjunction with complementary “harbors” 125 as a second structure. Asshown in FIG. 1A, the valve member 110 may be attached to or comprise aring 100. The ring 100 includes a plurality of “buttons” 105 or “bumps”located on its outer surface at defined intervals around thecircumference of the ring 100. The device frame (not shown, for clarity)comprises a plurality of posts 135 attached to it on its interiorsurface and oriented in an axial direction, as shown in FIG. 1B. Theplurality of posts 135 are attached to the device frame at definedintervals around the inner circumference that match up with the buttons105 on the ring 100. Each post 135 includes on an interior surface aplurality of “harbors” 125 (for example, cut-out grooves). The ring 100may be locked to harbors 125 on a post 135 attached to a device frame(not shown) via the buttons 105 that comprise a quick release mechanism,allowing adjustment of the position of the valve member relative to thedevice frame along the longitudinal axis of the valve device, e.g.,along the aortic root axis, where the aortic valve is to be replaced.

In one aspect of this embodiment, pulling or pushing a safety catch mayactivate or deactivate the quick release mechanism. For example, uponactivation of the safety catch, the buttons 105 are activated such thatthey protrude outwardly from the outer surface of the ring 100, therebylocking into the harbors 125 of the post 135. Similarly, upondeactivation of the safety catch, the buttons 105 are deactivated suchthat they retract from the harbors 125 to appear substantially even withthe outer surface of the ring 100, thereby unlocking the valve memberfrom the device frame. In an alternative aspect of the invention, thebuttons 105 are spring loaded and activate and deactivate according towhether the spring is engaged or disengaged. As illustrated by onebutton 105 and a plurality of harbors 125 on one post 135 in FIG. 1B,the ring 100 may be docked in any one of several sets of harbors 125 onthe plurality of posts 135 attached to the device frame, allowingadjustments along the aortic root axis. Preferably the harbors 125 arespaced apart by about 0.5-3 mm. In the embodiment illustrated in FIGS.1A and 1B, the valve device comprises four pairs of first and secondstructures, however in other embodiments, the valve device may havethree pairs or as many as six or eight pairs of first and secondstructures.

As illustrated in another embodiment of the invention depicted in FIG.2, the adjustment mechanism may comprise a controlled snap-fit lockingmechanism comprising snap-fit pads 205 as a first structure inconjunction with posts 235 having complementary openings 239 as a secondstructure. In this embodiment, the valve member 210 is attached to orcomprises a ring 200. The ring 200 includes several snap-fit pads 205mounted underneath the ring 200 at defined intervals around thecircumference of the ring 200. The device frame (not shown, for clarity)comprises a plurality of posts 235 attached to it on its interiorsurface and oriented in an axial direction. The plurality of posts 235are attached to the device frame at defined intervals around the innercircumference that match up with the snap-fit pads 205 on the ring 200.Each post 235 includes a plurality of openings 239 on its interiorsurface and a safety slide 237 for locking a snap-fit pad 205 into anopening 239 of the post 235. Preferably the openings 239 are spacedapart by about 0.5-3 mm. Each of the snap-fit pads 205 includes anangular head 206 for insertion into an opening 239 of a post 235. Uponrelease of the safety slide 237, the valve member 210 may be adjusteduntil a snap-fit pad 205 engages a desired opening 239. The snap-fit pad205 then may be locked into the opening 239 of the post 235 via theangular head 206 and the safety slide 237.

In one aspect of this embodiment, the snap-fit pad 205 may bespring-loaded and may be locked into an opening 239 of the post 235after the angular head 206 of the snap-fit pad 205 engages an opening239, by depressing the safety slide 237 to allow it to move proximally.The new more proximal position of the safety slide 237 partiallyunblocks the opening 239, thereby locking the angular head 206 of thesnap-fit pad 205 into the opening 239. In another embodiment, thesnap-fit pad 205 may be unlocked from an opening 239 of a post 235 by areverse method, i.e., by moving the safety slide 237 distally to unblockthe opening 239 and permit the angular head 206 to disengage from theopening 239. In still another embodiment, the safety slide 237 may bemoved either proximally or distally to unblock the opening 239. Thesafety slide 237 may be moved using pull wires or push-rods. In theembodiment illustrated in FIG. 2, the valve device comprises four pairsof first and second structures, however in other embodiments, the valvedevice may have three pairs or as many as six or eight pairs of firstand second structures. The valve ring may be moved axially along theaortic root until a satisfactory location is achieved.

In still yet another embodiment of the invention illustrated in FIGS. 3Aand 3B, the adjustment mechanism comprises a ratchet mechanismcomprising a valve member 310 attached to or comprising a ring 300 as afirst structure in conjunction with posts having complementaryratchets—a ratchet post 335—as a second structure. The device frame (notshown, for clarity) comprises a plurality of ratchet posts 335 attachedto it on its interior surface and oriented in an axial direction. Theplurality of ratchet posts 335 are attached to the device frame atdefined intervals around the inner circumference. The ratchet posts 335include a plurality of grooves 337. Preferably the grooves 337 arespaced apart by about 0.5-3 mm. As illustrated in FIG. 3A, the grooves337 a may be angled distally (e.g., away from the aorta) or, as depictedin FIG. 3B, the grooves 337 b may be angled proximally (e.g., toward theaorta). The grooves 337 operate to lock the ring 300, and therefore thevalve member 310, at a particular position relative to the device frame.The ring 300 may be constricted to a relatively small radius to alloweasier movement and fine tuning. In the embodiment illustrated in FIGS.3A-3B, the valve device comprises four pairs of first and secondstructures, however in other embodiments, the valve device may havethree pairs or as many as six or eight pairs of first and secondstructures. The leaflet ring is moved axially along the aortic rootuntil a satisfactory location is achieved.

As depicted in another embodiment of the invention illustrated in FIGS.4A-4C, the adjustment mechanism comprises a snap-rivet locking mechanismcomprising flexible pads 403 having at least one angular rib 404 as afirst structure in conjunction with posts 435 having a plurality ofcomplementary angular grooves 437 as a second structure. The valvemember 410 is attached to or comprises a ring 400. The ring 400 includesa plurality of flexible pads 403 attached thereto. Each of the flexiblepads 403 includes at least one angular rib 404 that runs perpendicularto the length of the pads. The device frame (not shown, for clarity)comprises a plurality of posts 435 each comprising a plurality ofangular grooves 437 for interlocking with the at least one angular rib404 of the flexible pads 403. Preferably the angular grooves 437 arespaced apart by about 0.5-3 mm. The plurality of posts 435 are attachedto the device frame on its interior surface and oriented in an axialdirection, and are attached to the device frame at defined intervalsaround the inner circumference that match up with the flexible pads 403on the ring 400. In the embodiment illustrated in FIG. 4, the valvedevice comprises four pairs of first and second structures, however inother embodiments, the valve device may have three pairs or as many assix or eight pairs of first and second structures. The position of thevalve member 410 may be adjusted by moving the ring 400 with theflexible pads 403 retracted (retracted flexible pads 403 a) in thedevice frame axially with respect to the aortic root until asatisfactory location is achieved, as shown in FIG. 4A. The flexiblepads 403 may then be released, as shown in FIG. 4B, in a manner to allowtheir angular grooves 437 to be engaged (engaged flexible pads 403 b)and interlocked with the angular grooves 437 of the posts 435, as shownin FIG. 4C.

In yet another embodiment of the invention illustrated in FIG. 5, thathas particular applicability for a modular valve device, the adjustmentmechanism operates separately from a locking mechanism. In thisembodiment, a valve assembly 510, for example, may be loosely anchoredto the support structure 520, for example to a post of the supportstructure, via a flexible string 548. The flexible string alternativelymay be a net or a flexible wire such as a pull wire, for example. Theflexible string 548 may be attached to the valve assembly via a firstanchor 549 a and may connect the valve assembly 510 to the supportstructure 520 by looping through the support structure. In oneembodiment, a free end of the flexible string may exit the proximal endof the delivery device (i.e., outside the body) that is used to deliverthe modular valve. In another embodiment, the non-anchored end of theflexible string may be connected to the delivery device. In thisembodiment, mechanisms within the delivery system may assistmanipulation of the flexible string 548 to adjust the position of thevalve assembly relative to the support structure. Such mechanisms arewithin the skill in the art. As illustrated in FIG. 5, the flexiblestring 548 is connected to the first anchor 549 a and loops around ahole or string loop (not shown) on the support structure to form asecond anchor 549 b to loosely suspend the valve assembly 510. Bymanipulating the free end of the flexible string, the flexible string548 may be used to finely adjust the position of the valve assembly 510relative to the support structure 520 before locking the valve assemblyto the support structure using a locking mechanism.

FIG. 6a depicts yet another embodiment of the invention in which theposition of the valve member 610 may be axially and angularly fine tunedto its optimal location by pushing and pulling it along a helix rail605. In this embodiment the first structure is a helix rail 605 and thesecond structure is a roller 607 attached to the device frame 620. Asillustrated in FIG. 6a , the helix rail 605 preferably is connected tothe valve member, for example a valve component, and the rollers 607which cooperate with the helix rail 605 are attached to the device frame620, or support structure. The helix rail 605 and rollers 607 cooperateto permit rotation of the valve member 610 around a longitudinal axisand along one of the “lines” of the helix rail 605, as illustrated.Adjustment of the valve member 610 may be accomplished by pulling orpushing it along the helix rail 605 in a manner that causes the valvemember 610 to glide through the rollers 607 in the indicated directions.The valve member may be moved along the helix rail using pull wires orpush-rods. The helix rail may be a wire, and in particular may be ashape memory wire. Where the valve device is a modular valve device, thehelix rail 605 may be manufactured of a shape memory metal, for example,Nitinol and may be comprised of several interconnected segments. Theshape memory helix rail 605 may be delivered in a delivery form thatpermits a small delivery profile, and then the shape memory helix rail605 may be triggered to revert to a preconditioned helical coil shapeafter deployment (as shown in FIG. 6a ). For example, the shape memoryhelix rail 605 may be delivered uncoiled or coiled so as to achieve asmaller delivery diameter than the diameter of the preset helix. Thepitch of the preconditioned helical coil shape of the helix rail 605 maybe approximately 0.5-2 mm. However, other incremental pitches suitablefor the appropriate degree of fine adjustment may also be used. Whereused with a modular valve device, the helix rail 605 may be deployedwith the valve module (for example a valve component or a series ofvalve sections) from the delivery system into the support structure for“automatic” subassembly and connection to the rollers 607.

In an alternative of the embodiment of FIG. 6a , the valve member 610′may be axially and angularly fine tuned to its optimal location bypushing and pulling it along a helix groove 615, as depicted in FIG. 6b. In this embodiment, the helix groove 615 may be the second structureon the device frame 620′, and the first structure may be a plurality ofcomplementary protrusions 617 located on the valve member 610′. Theprotrusions 617 may be fixed or spring-loaded for engagement with thehelix groove 615.

In an alternative of the embodiment of FIG. 6, the valve member may beaxially and angularly fine tuned to its optimal location by pushing andpulling it along a helix groove (not shown). In this embodiment, thehelix groove may be the second structure on the device frame, and thefirst structure may be a plurality of complementary protrusions locatedon the valve member. The protrusions may be fixed or spring-loaded forengagement with the helix groove.

In most of the above-described embodiments, as is readily recognized bythe skilled artisan based on the descriptions herein, the position ofthe structures designated first and second structures may be reversed.For example, the structure designed a first structure on the valvemember may be provided as a second structure on the device frame and thecomplementary structure designated as a second structure on the deviceframe may be provided as a first structure on the valve member.

As depicted in FIG. 7, a device frame 720 or support structure, which inthis embodiment is illustrated as a stent, may include a post 735 aspart of a 3-dimensional device frame. FIG. 7 illustrates how a post 735in accordance with any of the embodiments of FIGS. 1-7 may be attachedto a device frame 720 that is a stent without interfering with theexpandability of the structure. Preferably the post 735 is sufficientlyflexible to not unduly interfere with the axial flexibility of thedevice frame but sufficiently stiff to function as needed in theparticular embodiment in which it is used. Posts 735 may be comprised ofthe same material as the device frame or a comparable material that doesnot chemically interact with the material of the device frame. Thepresent invention encompasses substituting the post on the device framewith a groove, where appropriate.

The adjustment mechanisms may be manufactured from metals or non-metals.The base of the valve member, in particular the ring structure, may bemade of a metal or a polymer, preferably a deformable polymer. Where thevalve device is a modular valve device, the ring structure may be aself-assembly member in its pre-set configuration, as described in¶¶36-38 and FIGS. 2a-10 of co-pending U.S. application Ser. No.12/686,338 (self-assembly), filed on date even herewith, whichapplication is incorporated herein by reference.

The adjustment mechanism of the present invention is applicable to allpercutaneous prosthetic valve devices, but is particularly useful inconjunction with a modular valve devices. Locking mechanisms may be usedto secure or attach together the device frame and valve member, providedthe locking mechanism is compatible with the particular adjustmentmechanism being used. Examples of locking mechanisms useful in attachingtogether device modules of a modular valve device are described in¶¶50-58 and FIGS. 5a-6a of priority U.S. application No. 61/144,007, in¶¶48-51, 84-113 and FIGS. 7-15 of co-pending U.S. application Ser. No.12/686,335 (modular), filed on date even herewith, which areincorporated herein by reference. The locking mechanisms preferably arefittings of the kind that are easily engaged from a remote location, yetalso provide a secure fitting that will not disengage during use.

The invention also may be applied to pre-assembled percutaneous valvedevices. Pre-assembled valve devices are delivered to the affectedvessel as one piece, and adjustment of the valve's position is notpossible after implantation at the target site. Thus the presentinvention encompasses incorporating the novel fine adjustment mechanismsinto the manufacture of preassembled percutaneous valves, so that thefirst and second structures having complementary first and secondconfigurations are in place on members of the pre-assembled device priorto delivery (i.e., outside the body). Examples of preassembled,percutaneous prosthetic valves into which the mechanisms of the presentinvention may be incorporated are described, for example, in U.S. Pat.Nos. 5,411,552 and 6,893,460, and include, for example, the CoreValveRevalving™ System from Medtronic/CoreValve Inc. (Irvine, Calif., USA),Edwards-Sapien or Cribier-Edwards valves from Edwards Lifesciences(Irvine, Calif., USA), and devices in development by, for example,AortTx (Palo Alto, Calif., USA), Sadra Medical, Inc. (Campbell, Calif.,USA), Direct Flow Medical (Santa Rosa, Calif., USA), Sorin Group(Saluggia, Italy), and any other variations of prosthetic valves.Previous methods of adjusting the position of the valve involverepositioning the frame—or stent. See U.S. Patent Pub. 2005/0137688 toSalahieh et al; Buellesfeld, L., et al., “Percutaneous Implantation ofthe First Repositionable Aortic Valve Prosthesis in a Patient WithSevere Aortic Stenosis,” CATHETERIZATION CARDIOVASCULAR INTERVENTIONS,71:579-584 (2008); Zegdi, R., et al., “A Repositionable Valve Stent forEndovascular Treatment of Deteriorated Bioprostheses,” Journal AmericanCollege Cardiology, 48:1365-1368 (2006). Such repositioning methods donot permit fine adjustment of the valve position and are less accurate,because one can reasonably expect that any errors in positioning in thefirst instance are likely to be repeated in subsequent instances. Bycontrast, the present invention permits fine adjustment of the valveposition, in that the valve may be incrementally moved into the correctposition, an approach that improves the accuracy of placement by aninterative process rather than random placement, as repositioningmethods do.

It is important that a prosthetic valve device is placed in a vessel (orlumen) with precision to ensure proper valve function and safety to thepatient. Accordingly, the apparatus and method of the invention may beused in conjunction with the placement system and method of placing amodular device, which are described in priority U.S. application No.61/144,007 at ¶67-82 and FIGS. 7a-8, and co-pending U.S. patentapplication Ser. No. 12/686,337, entitled “A System and Method forPlacing a Percutaneous Valve Device,” at ¶24-42 and FIGS. 1a-2, filed ondate even herewith, which applications are incorporated herein byreference.

The embodiments described above are merely illustrative and those ofordinary skill in the art will understand from the teachings herein thata range of mechanisms exists to allow for controlled, relative motionbetween two structures. For example, other contemplated first and secondstructures having complementary configurations are: notches at variousaxial/angular positions along a support structure that allows a valvedevice to be removably reset among the various positions; hooks/clampsthat allow the valve device to be anchored in different locations to asupport structure; wires along a support structure that provide a trackfor, e.g., eyelets on the valve module; or, any other mechanism forcausing controlled position adjustment of one structure relative toanother.

It will be appreciated by persons having ordinary skill in the art thatmany variations, additions, modifications, and other applications may bemade to what has been particularly shown and described herein by way ofembodiments, without departing from the spirit or scope of theinvention. Therefore it is intended that scope of the invention, asdefined by the claims below, includes all foreseeable variations,additions, modifications or applications.

What is claimed is:
 1. An apparatus for adjusting the position of avalve member of a percutaneous valve device, comprising: a firstadjustment structure located on said valve member; and a secondadjustment structure located on a device frame; wherein said valvemember and said device frame together comprise said valve device, saidpercutaneous valve device having a first configuration for percutaneousdelivery and a second configuration as a working configuration; andwherein said first adjustment structure has a configuration that fitstogether in a complementary manner with a configuration on said secondadjustment structure within a range of relative positions between thevalve member and device frame; said apparatus configured to allowadjustment of an angular position of said valve member relative to saiddevice frame; wherein said valve device is a modular valve device, saidvalve member and device frame being configured to be deliveredseparately and assembled into said valve device after deployment fromsaid delivery device.
 2. The apparatus of claim 1, wherein the firstadjustment structure is a helix rail and the second adjustment structureis a roller.
 3. The apparatus of claim 2, wherein the helix rail androller cooperate to permit rotation of said valve member around alongitudinal axis of the percutaneous valve device.
 4. The apparatus ofclaim 2, wherein said valve member is adapted to permit pushing andpulling thereof along a helix rail.
 5. The apparatus of claim 4, furthercomprising a pull-wire to affect movement of the valve member.
 6. Theapparatus of claim 2, wherein the helix rail is a wire.
 7. The apparatusof claim 2, wherein the helix rail is formed of a shape-memory material.8. The apparatus of claim 2, wherein the helix rail is a helical coil.9. The apparatus of claim 8, wherein the first and second adjustmentstructures cooperate to permit a range of relative positions betweensaid valve member and said device frame along a longitudinal axis of thepercutaneous valve device in said expanded configuration.
 10. Theapparatus of claim 1, wherein the first adjustment structure is aplurality of complementary protrusions located on said valve member andthe second adjustment structure is a helix groove, the protrusionsadapted for engagement with the helix groove.
 11. The apparatus of claim10, wherein the protrusions are fixed or spring-loaded.
 12. A systemcomprising: a percutaneous valve device, said valve device comprising afirst adjustment structure on a valve member, and a second adjustmentstructure located on a device frame; wherein said valve member and saiddevice frame together comprise said percutaneous valve device, saidpercutaneous valve device having a first configuration for percutaneousdelivery and a second configuration as a working configuration; andwherein said first adjustment structure has a configuration that fitstogether in a complimentary manner with a configuration on said secondadjustment structure within a range of relative positions between thevalve member and device frame; said percutaneous delivery deviceconfigured to allow adjustment of an angular position of said valvemember relative to said device frame; and a delivery device forpercutaneously delivering and deploying said valve device; wherein saidvalve device is a modular valve device, said valve member and deviceframe being configured to be delivered separately and assembled intosaid valve device after deployment from said delivery device.
 13. Thesystem of claim 12, wherein the first adjustment structure is a helixrail and the second adjustment structure is a roller.
 14. The system ofclaim 13, wherein the helix rail and roller cooperate to permit rotationof said valve member around a longitudinal axis of the percutaneousvalve device.
 15. The system of claim 13, wherein said valve member isadapted to permit pushing and pulling thereof along a helix rail. 16.The system of claim 15, further comprising a pull-wire to affectmovement of the valve member.
 17. The system of claim 13, wherein thehelix rail is a wire.
 18. The system of claim 13, wherein the helix railis formed of a shape-memory material.
 19. The system of claim 13,wherein the helix rail is a helical coil.
 20. The system of claim 19,wherein the first and second adjustment structures cooperate to permit arange of relative positions between said valve member and said deviceframe along a longitudinal axis of the percutaneous valve device in saidworking configuration.
 21. The system of claim 12, wherein the firstadjustment structure is a plurality of complimentary protrusions locatedon said valve member and the second adjustment structure is a helixgroove, the protrusions adapted for engagement with the helix groove.22. The system of claim 21, wherein the protrusions are fixed orspring-loaded.
 23. The system of claim 12, further comprising aposition-maintaining means.
 24. The system of claim 12, wherein saidvalve member is a valve module and said device frame is a supportstructure.
 25. The system of claim 12, wherein said delivery device is acatheter.
 26. A method of adjusting the position of a valve member of apercutaneous valve delivery system, the method comprising: providing adelivery device containing a percutaneous valve device, said valvedevice comprising a first adjustment structure on said valve member anda second adjustment structure located on a device frame, wherein saidvalve member and said device frame together comprise said percutaneousvalve device, said percutaneous valve device having a firstconfiguration for percutaneous delivery and a second configuration as aworking configuration, and wherein said first adjustment structure has aconfiguration that fits together in a complimentary manner with aconfiguration on said second adjustment structure within a range ofrelative positions between the valve member and device frame; saidpercutaneous delivery device configured to allow adjustment of anangular position of said valve member relative to said device frame;deploying said percutaneous valve device from said delivery device andexpanding said percutaneous valve device to form said secondconfiguration; and adjusting the angular position of said valve memberindependently of and relative to a position of said device frame viasaid first and second adjustment structures.
 27. The method of claim 26,wherein said valve device is a modular valve device, said valve memberis a valve module, and said device frame is a support structure; whereinsaid deploying step includes deploying said valve module and deployingsaid support structure; said method further comprising assembling saidvalve module and said support structure into said valve device.
 28. Themethod of claim 26, wherein said valve device further comprises aposition-maintaining means, said method further comprising: locking saidfirst and second adjustment structures together via saidposition-maintaining means.
 29. The method of claim 26, wherein saiddelivery device further comprises a pull wire; said method furthercomprising using said pull wire to adjust said angular position of saidvalve member relative to said device frame.
 30. The method of claim 27,wherein said method further comprises locking said valve module and saidsupport structure together using a locking mechanism.